Copyleft Clinical Trial Results. You Must Redistribute Slides SEISMIC Trial The Safetyand Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) using an Injection Catheter Trial The Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) using an Injection Catheter Trial

SEISMIC Trial Presented at ACC / i in Chicago Presented by Dr. Patrick W. Serruys SEISMIC Trial Copyleft Clinical Trial Results. You Must Redistribute Slides

SEISMIC Trial: Background Evaluated the safety and efficacy of injecting patient’s own skeletal muscle cells into scarred myocardium using a needle-tipped catheter.Evaluated the safety and efficacy of injecting patient’s own skeletal muscle cells into scarred myocardium using a needle-tipped catheter. Skeletal muscle cells have been shown to be superior to other muscle cell types in pre- clinical studies¹.Skeletal muscle cells have been shown to be superior to other muscle cell types in pre- clinical studies¹. Presented at SCAI/ACC i2 08 Summit ¹ E. Meliga, HJ Duckers, R Spencer, PW Serruys. Rationale and interim analysis data from the SEISMIC study. EuroIntervention Supplement (2007) 2 B84-B88.

SEISMIC Trial: Study Design  Primary Safety Endpoint: Incidence of procedural and device related serious adverse events.  Efficacy Endpoints: Change in global LVEF by MUGA scan, change in NYHA classification of heart failure, distance achieved during 6 minute walk test. Cell therapy 586 ± 193 x 106 cells n=31 Optimal medical treatment n=16 47 patients with congestive heart failure prior to randomization Prospective. Randomized. Multicenter. Mean follow-up 6 months 66% received cell therapy and 34% received optimal medical treatment. Presented at SCAI-ACCi2 08 Summit R 6 mos. follow-up 6 mos. follow-up Copyleft Clinical Trial Results. You Must Redistribute Slides

There were 15 incidences of sustained arrhythmia in the cell therapy group vs. 14 incidences in the medical treatment control group.There were 15 incidences of sustained arrhythmia in the cell therapy group vs. 14 incidences in the medical treatment control group. Incidence of adverse events SEISMIC Trial: Primary Safety Endpoint Presented at SCAI/ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides

SEISMIC Trial: Efficacy Endpoint Presented at SCAI/ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides The cell therapy group was able to walk an additional 60.3 ± 54.1 meters in the 6 minute walk test. The cell therapy group was able to walk an additional 60.3 ± 54.1 meters in the 6 minute walk test. The medical therapy group walked an additional 0.4 ± meters in the same test. The medical therapy group walked an additional 0.4 ± meters in the same test. The cell therapy group was able to walk an additional 60.3 ± 54.1 meters in the 6 minute walk test. The cell therapy group was able to walk an additional 60.3 ± 54.1 meters in the 6 minute walk test. The medical therapy group walked an additional 0.4 ± meters in the same test. The medical therapy group walked an additional 0.4 ± meters in the same test.

n =1 NYHA HF status improvement (%) n =3 Cell therapy Medical treatment SEISMIC Trial: Efficacy Endpoint cont. NYHA HF status deterioration (%) Cell therapy Medical treatment n =5 n =1 Presented at SCAI-ACC i2 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides

Global EF (%) Global EF (%) SEISMIC Trial: Efficacy Endpoint at 6 months Presented at SCAI-ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides Global ejection fraction was higher in the medical treatment group compared to the cell therapy group after 6 month follow-up.Global ejection fraction was higher in the medical treatment group compared to the cell therapy group after 6 month follow-up.

SEISMIC Trial: Efficacy Endpoint at 6 months Presented at SCAI/ACC i2 08 Summit Copyleft Clinical Trial Results. You Must Redistribute Slides End Systolic LV diameter (mm) 39.4±2.7mm 54.5±7.1mm

Copyleft Clinical Trial Results. You Must Redistribute Slides SEISMIC Trial: Limitations Future trials may consider including a larger sample size to appropriately power the study.Future trials may consider including a larger sample size to appropriately power the study. Presented at SCAI/ACC i2 08 Summit

Copyleft Clinical Trial Results. You Must Redistribute Slides SEISMIC Trial: Summary Presented at SCAI/ACC i2 08 Summit Autologous myoblast implantation in patients with congestive heart failure is feasible.Autologous myoblast implantation in patients with congestive heart failure is feasible. Myoblast implantation may improve symptoms of heart failure.Myoblast implantation may improve symptoms of heart failure. There was no significant effect in ventricular thickness or LV ejection fraction between the cell therapy group and the medical treatment group at 6 months.There was no significant effect in ventricular thickness or LV ejection fraction between the cell therapy group and the medical treatment group at 6 months.